APA and PAS Training for Gait Initiation in Parkinson's Disease

NCT06363071 | Recruiting

• 1 other identifier: 202000495A3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability.

Conditions

Parkinson Disease

Keywords

Gait Initiation; Balance training; Anticipatory postural adjustments; Paired associative stimulation (PAS); Transcranial magnetic stimulation (TMS)

Outcome Measures

Primary Outcomes (9)

• Balance Performance

  Measured by the duration the stance can be maintained. Unit：seconds(s)

  Baseline, 4 weeks and 8 weeks.

• COP Path Length in Balance Tasks

  The total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability. Unit：millimeters(mm)

  Baseline, 4 weeks and 8 weeks.

• COP Displacement in Balance Tasks

  Measures of COP movement in the anterior-posterior (AP) and medial-lateral (ML) directions, offering insights into the directional tendencies of balance control. Unit：millimeters(mm)

  Baseline, 4 weeks and 8 weeks.

• Motor Evoked Potentials (MEPs)

  MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit：millivolts (mV)

  Baseline, 4 weeks and 8 weeks.

• Intracortical Facilitation (ICF)

  ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.

  Baseline, 4 weeks and 8 weeks.

• Intracortical Inhibition (ICI)

  ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.

  Baseline, 4 weeks and 8 weeks.

• Walking Speed

  The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).

  Baseline, 4 weeks and 8 weeks.

• Step Length

  The linear distance between the two ankles, typically expressed in centimeter(cm).

  Baseline, 4 weeks and 8 weeks.

• Step Time

  The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.

  Baseline, 4 weeks and 8 weeks.

Secondary Outcomes (7)

• COP Velocity in Balance Tasks

  Baseline, 4 weeks and 8 weeks.

• COP Area in Balance Tasks

  Baseline, 4 weeks and 8 weeks.

• Double Support Time

  Baseline, 4 weeks and 8 weeks.

• Single Support Time

  Baseline, 4 weeks and 8 weeks.

• Swing Time

  Baseline, 4 weeks and 8 weeks.

Study Arms (5)

Stage 1:Healthy people

EXPERIMENTAL

To establish PAS baseline and reliability.

Procedure: Paired associative stimulation

Stage 2:PD people

EXPERIMENTAL

To establish stage 3 training protocol.

Procedure: Paired associative stimulation

Stage 3:PD people

NO INTERVENTION

Control group.

Stage 3: PD APA training group

EXPERIMENTAL

Weight shift training and APA feedback.

Other: Weight shift training and APA feedback

Stage 3:PD PAS group

EXPERIMENTAL

Using PAS to regulate brain plasticity

Procedure: Paired associative stimulation

Interventions

Paired associative stimulation PROCEDURE

Use TMS combine ES to stimulate TA nerve and M1 cortical

Also known as: PAS group

Stage 1:Healthy people; Stage 2:PD people; Stage 3:PD PAS group

Weight shift training and APA feedback OTHER

Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.

Also known as: • APA training group

Stage 3: PD APA training group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Musculoskeletal injuries on legs.
• Osteoporosis.
• PD subjects:
• \- Clinical diagnosis of Parkinson disease.
• Musculoskeletal injuries on legs
• Osteoporosis.
• Any peripheral or central nervous system injury or disease patients.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ya-Ju Chang, PhD

CONTACT

+88632118800; yjchang@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 12, 2024
• Study Start: June 13, 2022
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)